News Release
Independent Panel Recommends Concluding Clinical
Endpoint Trial of REMUNE; Agouron Pharmaceuticals,
Inc. and The Immune Response Corporation To Pursue
Alternative Regulatory Strategy
CARLSBAD, Calif. and LA JOLLA, Calif., May 17 /PRNewswire/ -- The Immune Response
Corporation (Nasdaq: IMNR - news) and Agouron Pharmaceuticals, Inc. (Nasdaq: AGPH - news)
announced today that an independent Data Safety Monitoring Board (DSMB) completed a second
interim analysis of the 2500-patient, placebo-controlled, Phase III clinical endpoint trial to evaluate
the immune-based therapy REMUNE(TM) added to patients' other anti-HIV therapy. The DSMB
recommended the trial be concluded at this time because differences in clinical endpoints were not
observed between treatment groups and because extending the trial would be unlikely to provide
sufficient additional clinical endpoints to permit statistically significant differences between the
treatment groups to be observed in the near term. The number of HIV-associated clinical endpoints
observed in the trial was far less than originally anticipated, which was believed to be the result of
increasing use of Highly Active Antiretroviral Therapy (HAART) including HIV protease inhibitors,
after the trial was initiated.
The Immune Response Corporation and Agouron Pharmaceuticals, Inc. reported that separate
analysis of a cohort of 250 patients randomly pre-selected for surrogate marker analysis, showed a
significantly greater reduction in viral load (level of HIV RNA in plasma) after 48 and 96 weeks of
treatment and significantly greater increases in lymphoctye proliferation in those who added
REMUNE to their underlying anti-retroviral therapy, compared with those who did not. The
Companies also reported that Agouron plans to initiate two additional phase III surrogate marker
trials of REMUNE in light of an agreement previously reached with the Food and Drug
Administration that an application for the marketing of REMUNE could be submitted based upon
favorable virological endpoints.
''We thank the patients and clinical investigators who participated in this trial, a trial that has yielded
findings significant to the design of future studies. While HAART, which became the standard of care
after we initiated this trial, has been an enormous benefit to HIV patients, it has made it exceedingly
difficult to conduct a trial based upon reaching clinical endpoints,'' according to Dennis J. Carlo,
Ph.D., president and chief executive officer of The Immune Response Corporation. ''The significant
improvements in viral load and in lymphocyte proliferation observed in the REMUNE arm of the
250 patient cohort confirm previous results and provide support for a proposed rollover study for
patients currently enrolled in the clinical endpoint study. This rollover study, which is planned to be
initiated in the next 2-3 months after FDA clearance, is intended to evaluate the ability of patients to
maintain viral load suppression after discontinuation of anti-retroviral drugs.''
''We believe the improved control of viral load observed in the clinical endpoint study provides
strong support for new pivotal clinical trials of REMUNE to be based on virologic markers,'' said
Peter Johnson, Agouron's president and chief executive officer. ''Concluding the clinical endpoint
trial at this time also presents a unique opportunity to address a very contemporary question: can
immune-based therapy extend the duration of the anti-HIV response induced by HAART under the
most challenging conditions? The potential to produce this effect remains one of REMUNE's most
important attributes.''
The Immune Response Corporation and Agouron Pharmaceuticals, Inc. entered into a collaboration
in 1998 for the final development and commercialization of REMUNE, an immune-based therapy
for the treatment of HIV infection.
''We look forward to working with Agouron on the next steps in our collaboration, while at the
same time we continue our efforts to move ahead from our non-binding terms of collaboration with
the University of Maryland Biotechnology Institute, announced May 10, 1999, toward a binding
agreement regarding chemokine and HAF (hCG associated factor) technology and related matters,''
Dr. Carlo explained. |
